MAUDE Adverse Event Report: ZIMMER, INC. NEXGEN ARTICULAR SURFACE WITH HINGE POST EXTENSION; PROSTHESIS, KNEE

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Information (3190)

Event Date 06/30/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in process of being returned for investigation.Once the evaluation is completed, a supplemental medwatch 3500a will be submitted.Product expected, not yet returned.

Event Description

It was reported that during a knee implantation the pin would not pass through the femur into the articular surface.Attempts have been made and no further information has been provided.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

Complaint sample was evaluated and the reported event could not be confirmed.The articular surface and hinge post extension were returned and examined.No major damage was found on the articular surface.The post extension hex head was found damaged and deformed.Dimensional analysis was completed for both the hinge extension and articular surface.Length of the hinge post extension was found out of tolerance; however, these damages were attributed to removal attempts.The other dimensions were found within tolerance.Device history record was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action is required.Root cause can not be determined as the device analysis indicated that the device met specification.A summary of the investigation has been sent to the complainant.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Manufacturer Narrative

If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Manufacturer Narrative

Udi: (b)(4).If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: NEXGEN ARTICULAR SURFACE WITH HINGE POST EXTENSION
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6736745
• MDR Text Key: 80820615
• Report Number: 0001822565-2017-05037
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PK013385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 00588004017
• Device Lot Number: 63485412
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 100